Quality Associate Pharma Haarlem

Vacatureomschrijving

Our client is looking for candidates to join with a growing busy freight forwarding company based in Nieuw-Vennep, specialized in shipping pharmaceuticals and related products.
Established back in 1986, our client is licensed by the Dutch health regulator, Farmatec, and is involved in all aspects of logistics for the pharmaceutical industry. With sites at both London Heathrow and Amsterdam, the company is involved in clinical trials, handling R&D material consignments, shipping active ingredients, controlling finished product movements, storing medicines for pick and pack, to being involved in high value-controlled drug shipments, and generally involved in multiple parts of the pharma industry.

Shipments move via a mix of airfreight and our own temperature-controlled vehicles, many using specialist temperature-controlled packaging to ensure the correct temperature conditions are maintained during transit. Our procedures are designed to ensure the characteristics of the products we handle are not changed by the conditions they are exposed to during transit, e.g., extreme temperatures.
Applicants should already have experience in a Quality role within the pharmaceutical or forwarding industry, with a proven track record helping to run a Quality Management System (QMS). Applicants may be more experienced with systems such as ISO, rather than GDP (Good Distribution Practice), so full training on the specifics of storing and shipping pharmaceuticals will be provided both on the job and from outside sources. The existing Quality team is currently made up of a company director, a Quality Manager, a Quality Associate and two external consultants. This role is for a Quality Associate to help manage the daily quality tasks at the Amsterdam site. Some experience in Health and Safety matters would also be beneficial.
The candidate will be required to demonstrate a high level of spoken and written English as 75% of the job is working with written documentation, and 25% taking part in internal, client and supplier audit situations. And a good understanding of Dutch would be beneficial too. The annual salary being offered would be commensurate with the applicant's experience.
This is ideally a full-time role, Monday to Friday, where the standard hours are between 0900 to 1730 Hrs. There are 25 days annual holiday plus the usual standard national holidays. And whilst this is an office-based position some home working is possible as required. Some overseas travel may be required, for the purposes of visiting the company’s London site, and critical supplies which need to be audited.

Key tasks include:

• Helping to run and maintain the eQuality Management System (eQMS);
• Reviewing and updating all company procedures;
• Reviewing and updating all Company Forms, Policies and Logs;
• Ensure all staff fully trained in appropriate procedures and elements of QMS relevant to their position;
• Take steps to ensure staff and partners comply with procedures and policies in place;
• Reviewing and updating all processes relating to the QMS and the company’s performance;
• Managing all temperature mapping requirements for vehicles and the premises;
• Managing all calibration requirements for the vehicles, premises and equipment;
• Managing the Corrective and Preventative Action (CAPA) system;
• Analyse data gathered in CAPA system and look for trends and opportunities for improvement;
• Managing warehouse temperature Continuous Monitoring System;
• Helping to manage the Quality processes in the company’s Amsterdam operation;
• Managing all existing suppliers and qualifying new ones as a critical partner into the QMS;
• Managing all overseas pharma network partners, qualifying them as suitable and keeping such records up to date;
• Hosting client audits on site;
• Conducting internal and supplier audits as and when necessary;
• Raising risk assessments on H&S and quality issues;
• Keeping up-to-date with current pharmaceutical distribution best practice, and the GxP regulations;
• Managing the company’s healthcare licences (WDA, API, MIA);
• Meeting with customers or suppliers when necessary;
• Generally helping with the administration of the office and its procedures;
• Answering e-mails and communications from suppliers and clients in relation to quality matters and CAPA investigations;
• Helping to manage the companies network in relation to quality matters;
• Managing all staff training requirements, identifying and arranging new training needs and ensuring individual staff training is kept up to date;
• Conduct new staff introductions to highlight company policies and QMS.

Gevraagd

IMPORTANT – Minimum and strict requirements:

• We need a complete employment history for the past 5 years.
• If there are no gaps in this history (other than weekends) then we don't need any further references.
• If there are however any gaps we need a reference from a professional person to confirm that they have known the candidate for the previous 5 years.

Aanbod

Solliciteren?

Neem dan contact op met:

Danny de Boer
DdB Werving & Selectie
Haarlem
Tel: 06-41961121
@: via de button "Solliciteer nu" op deze pagina.